A Phase II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Aplidin® as a 3-hour IV Infusion Every 2 Weeks, in Relapsing or Refractory Patients With Androgen-independent Prostate Adenocarcinoma..

PharmaMar2 sites in 1 country8 target enrollmentFebruary 2005

ConditionsProstate Cancer

InterventionsAplidin (plitidepsin)

DrugsAplidin (plitidepsin)

Overview

Phase: Phase 2
Intervention: Aplidin (plitidepsin)
Conditions: Prostate Cancer
Sponsor: PharmaMar
Enrollment: 8
Locations: 2
Primary Endpoint: The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study to test the safety and efficacy of an investigational chemotherapy agent in patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the investigator conducting the study.

Detailed Description

Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United States. The majority of deaths occur in men with androgen-independent prostate cancer \[AIPC\]. Although 80% of men with advanced cancer will initially respond to androgen ablation with disease regression or stabilization, their malignancies become resistant to such therapy.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

March 2008

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

PharmaMar

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent before starting any study-specific procedure. If any patient is unable to give consent, it may be obtained from the patient's legal representative if in accordance with local laws and regulations.
•Men with castrate metastatic adenocarcinoma of the prostate, with the following characteristics:
•Confirmed pathological diagnosis.
•Metastatic disease (radiologically documented).
•All patients with chemical castration must have a serum testosterone level below 50 ng/ml. There is no need to document a serum testosterone in patients having a prior surgical castration
•Baseline PSA \> 5 ng/ml (according to the recommendations from the Prostate-Specific Antigen Working Group2).
•Androgen-independent progressive disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart:
•If PSA responded to a prior therapy, progression occurs when the PSA is 50% above the nadir level.
•If PSA did not respond to a prior therapy, progression occurs when the PSA increases by 25% or more above pretreatment levels.
•In both cases, the increase in absolute value PSA level must be at least 5 ng/ml, and must be confirmed by a second measurement a minimum of 1 week later.

Exclusion Criteria

•Prior therapy with Aplidin®.
•Concomitant therapy with any anti-tumor agent, including glucocorticoids at a daily dose greater than 10 mg prednisone or equivalent, except when they were indicated for symptom control, provided that disease progression was documented while on steroids.
•Small cell carcinoma of the prostate.
•More than two previous lines of systemic therapy for patient's castrate metastatic disease, considering biological agents or chemotherapy as systemic therapy.
•Patients with progressive measurable disease but without increased PSA value (according to the consensus recommendations) will not be considered eligible.
•Wash-out periods less than:
•6 weeks after the last dose of a nitroso-urea or high dose chemotherapy
•4 weeks after the last dose of other chemotherapies or biological agents
•6 weeks after the end of treatment with extensive external beam radiation (more than 25% of bone marrow distribution) or radionuclide therapy.
•4 weeks after the end of treatment with palliative radiation involving less than 25% of bone marrow reserves.

Arms & Interventions

Arm 1

Aplidin (Plitidepsin)

Intervention: Aplidin (plitidepsin)

Outcomes

Primary Outcomes

The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy

Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first

Secondary Outcomes

Objective Tumor Response According to RECIST(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
Progression Free Survival (PFS)(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
Overall Survival (OS)(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
Pain Improvement Rate(2-7 days for the pain stabilization required at baseline to ensure that baseline values are stable and reliable. The follow-up period was up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment)
PSA Slope Between Baseline PSA Value and Nadir After the Start of Treatment(From baseline until progression or initiation of another anticancer therapy, death or one year after the last treatment visit of the last patient, whichever occurred first.)